JP2013155148A - Uv laser printing method for intraorally disintegrating tablet - Google Patents
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本発明は、フィルムコーティングされた口腔内崩壊錠の表面に識別文字等をＵＶレーザー印刷する方法に関する。 The present invention relates to a method for UV laser printing identification characters on the surface of a film-coated orally disintegrating tablet.
医療現場では、錠剤やカプセル剤等の固形製剤の調剤ミスや服薬ミスを未然に防止するため、識別性の優れたものが求められている。その識別性を高める代表的な方法として、打錠用金型に刻印用加工を施し、錠剤表面に刻印する方法があるが、刻印部が欠損し易いなどの問題がある。そこで、錠剤表面にインクを用いてグラビアオフセット印刷をする方法やインクジェット印刷をする方法が開発され、実際にカタカナ文字等が印刷されているが、裸錠には印刷ができない問題がある。また、インクを使用するため、印刷の濃淡やインクのにじみ、未乾燥に伴う他錠の汚れ、文字かすれ等の不良が生じる問題や、インクや有機溶剤を使用するため環境面での問題もある。
この様な背景から、最近になって、特定の変色誘起酸化物（酸化チタン、黄色三二酸化鉄、三二酸化鉄）を分散させた錠剤等の表面に一定のレーザー光を照射することにより、鮮明な識別文字や記号を印刷することができるＵＶレーザー印刷技術が開発され、その詳細が開示されている（特許文献１）。
In the medical field, in order to prevent dispensing errors and medication errors in solid preparations such as tablets and capsules, those with excellent discrimination are required. As a typical method for improving the discrimination, there is a method of performing a stamping process on a tableting die and stamping on the tablet surface, but there is a problem that the stamped portion is easily lost. Therefore, a method of performing gravure offset printing using ink on the tablet surface and a method of performing ink jet printing have been developed and katakana characters are actually printed, but there is a problem that printing cannot be performed on a bare tablet. In addition, since ink is used, there are problems such as printing shading, ink bleeding, stains on other tablets due to undried, blurred characters, etc., and environmental problems due to the use of ink and organic solvents. .
Against such a background, recently, by irradiating the surface of a tablet or the like in which a specific discoloration-inducing oxide (titanium oxide, yellow iron sesquioxide, iron sesquioxide) is dispersed with a certain laser beam, it is clear. UV laser printing technology capable of printing various identification characters and symbols has been developed, and details thereof have been disclosed (Patent Document 1).
一方、近年の高齢化社会において錠剤の嚥下が困難な高齢者にも服用がし易い口腔内速崩壊錠が種々市販されている。しかし、それらの何れの錠剤も、速崩壊性を保持するため、フィルムコーティングが施されていない所謂「素錠」であり、輸送時ないし調剤時に摩損や欠けやすいなどの問題があった。そこで、口腔内速崩壊錠の特長を保持しつつ、高い強度を有するフィルムコーティング錠が提案された（特許文献２）。 On the other hand, in the recent aging society, various intraoral quick disintegrating tablets that are easy to take even for elderly people who have difficulty swallowing tablets are commercially available. However, all of these tablets are so-called “plain tablets” that are not coated with a film in order to maintain rapid disintegration, and have problems such as being easily worn or chipped during transportation or dispensing. Therefore, a film-coated tablet having a high strength while retaining the features of an intraoral quick disintegrating tablet has been proposed (Patent Document 2).
しかし、特許文献１及び特許文献２には、フィルムコーティングされた口腔内速崩壊錠に識別文字等をＵＶレーザー印刷した例は全く記載されていない。 However, Patent Document 1 and Patent Document 2 do not describe any examples in which identification characters or the like are printed on a film-coated intraoral quick disintegrating tablet by UV laser.
特許文献１ 国際公開２００６／１２６５６１号
特許文献２ 特開２０１０−２４８１０６号公報
Patent Document 1 International Publication No. 2006/126561 Patent Document 2 JP 2010-248106 A
前記特許文献１及び特許文献２に基づいて、酸化チタン等を含有するコーティング剤でフィルムコーティングした口腔内速崩壊錠を製造し、その表面にUVレーザー光を照射して識別文字を印刷すると、高い強度を有し、且つ、顕著な識別性を有する文字等が印刷された口腔内速崩壊錠が得られると考えられる。
そこで、本発明者らは、常法にしたがってコーティングが施されていない口腔内速崩壊錠を製造し、繁用されている種々のコーティング剤に酸化チタンを分散させてコーティングし、その表面に識別文字をＵＶレーザー印刷する方法について検討したところ、好ましいと考えられるコーティング剤、酸化チタンの使用割合、及びＵＶレーザーの照射条件を組合せても、識別できる文字等の印刷は得られるものの、小さな文字をも鮮明に判別可能なほどに識別性が顕著なものを得るのは困難であることが判った。
Based on Patent Literature 1 and Patent Literature 2, when an intraoral rapidly disintegrating tablet film-coated with a coating agent containing titanium oxide or the like is manufactured, and the identification characters are printed by irradiating the surface with UV laser light, it is high. It is considered that an intraoral quick disintegrating tablet on which characters and the like having strength and remarkable distinguishability are printed can be obtained.
Therefore, the present inventors manufactured an intraoral quick disintegrating tablet according to a conventional method, dispersed titanium oxide in various commonly used coating agents, coated, and identified the surface. When we examined the method of UV laser printing of characters, although it is possible to print distinguishable characters, etc. even if combining the coating agent considered to be preferable, the usage rate of titanium oxide, and the irradiation conditions of UV laser, small characters can be printed. However, it was found that it was difficult to obtain a material with distinctiveness that was clearly distinguishable.
すなわち、本発明の課題は、フィルムコーティング口腔内速崩壊錠の表面に文字等を識別顕著にＵＶレーザー印刷する方法を提供することにある。 That is, an object of the present invention is to provide a method for remarkably UV laser-printing characters and the like on the surface of a film-coated intraoral quick disintegrating tablet.
本発明者らは、上記課題を解決するため、種々のコーティング剤を使用し、酸化チタンの使用割合やＵＶレーザーの照射条件を検討するなかで、ポリビニルアルコール・アクリル酸・メタクリル酸・メチル共重合体を使用して錠剤の表面をコーティングし、一定の条件下にＵＶレーザー照射すると、錠剤の表面に鮮明な文字を印刷できることを見出した。さらに検討を加え、本発明を完成することができた。 In order to solve the above-mentioned problems, the present inventors use various coating agents, and examine the usage ratio of titanium oxide and the irradiation conditions of the UV laser, and the polyvinyl alcohol / acrylic acid / methacrylic acid / methyl copolymer It has been found that when the surface of a tablet is coated using coalescence and UV laser irradiation is performed under certain conditions, clear letters can be printed on the surface of the tablet. Further studies were made and the present invention was completed.
本発明によれば、下記（１）〜（４）の方法を提供することができる。
（１）ポリビニルアルコール系重合体から選ばれた化合物と変色誘起金属酸化物とが均一に分散したコーティング液でフィルムコーティングされた口腔内崩壊錠の表面に、ＵＶレーザーを照射することにより識別文字又は記号を印刷することを特徴とする口腔内崩壊錠のＵＶレーザー印刷方法。
（２）ポリビニルアルコール系重合体が、ポリビニルアルコール（部分けん化物）、ポリビニルアルコール・ポリエチレングリコール共重合体又はポリビニルアルコール・ポリビニルアルコール・アクリル酸・メタクリル酸メチル共重合体である前記（１）に記載の方法。
（３）変色誘起金属酸化物がアナターゼ型若しくはルチル型の酸化チタン、三二酸化鉄又は黄色三二酸化鉄である前記（１）に記載の方法。
（４）ポリビニルアルコール系重合体がポリビニルアルコール・アクリル酸・メタクリル酸メチル共重合体であり、金属酸化物がアナターゼ型酸化チタンである前記（１）に記載の方法。
According to the present invention, the following methods (1) to (4) can be provided.
(1) An identification character or a surface of an orally disintegrating tablet film-coated with a coating solution in which a compound selected from a polyvinyl alcohol-based polymer and a discoloration-inducing metal oxide are uniformly dispersed is irradiated with a UV laser. A UV laser printing method for orally disintegrating tablets, comprising printing a symbol.
(2) The polyvinyl alcohol polymer is polyvinyl alcohol (partially saponified product), polyvinyl alcohol / polyethylene glycol copolymer or polyvinyl alcohol / polyvinyl alcohol / acrylic acid / methyl methacrylate copolymer as described in (1) above. the method of.
(3) The method according to (1), wherein the discoloration-inducing metal oxide is anatase-type or rutile-type titanium oxide, iron sesquioxide, or yellow iron sesquioxide.
(4) The method according to (1), wherein the polyvinyl alcohol polymer is a polyvinyl alcohol / acrylic acid / methyl methacrylate copolymer, and the metal oxide is anatase titanium oxide.
本発明によれば、錠剤としての一定の強度を有し、口腔内崩壊錠の特長である速溶解性を保持する錠剤であって、自他識別性の高い文字等がレーザー印刷された錠剤を提供することができる。
また、本発明は、フィルムコーティングされた錠剤の表面に所謂マーキングする方法に関するものであるから、錠剤に含まれる医薬ないし生理活性物質に何ら影響を及ぼすことがなく、種々の医薬や生理活性物質に適用できる。
According to the present invention, there is provided a tablet having a certain strength as a tablet and retaining the fast dissolution characteristic of an orally disintegrating tablet, and which is laser-printed with characters or the like having high self-other distinguishability. Can be provided.
Further, the present invention relates to a so-called marking method on the surface of a film-coated tablet, so that it does not affect the medicine or physiologically active substance contained in the tablet, and can be applied to various medicines and physiologically active substances. Applicable.
本発明のレーザー印刷用口腔内崩壊錠を得るために用いる所謂「素錠」の製造方法は、特に困難はなく、常法にしたがって口腔内崩壊錠を製造すればよい。たとえば、医薬を流動層造粒機や高速撹拌造粒機等で造粒し、得られた顆粒に滑沢剤等の必要な添加物を加え混合後、ロータリー式打錠機等で成型することにより、製造できる。また、医薬に苦味がある場合等は必要に応じて医薬や顆粒にコーティングをしても良い。 The so-called “plain tablet” used for obtaining the orally disintegrating tablet for laser printing of the present invention is not particularly difficult, and the orally disintegrating tablet may be manufactured according to a conventional method. For example, the medicine is granulated with a fluid bed granulator or a high-speed agitation granulator, and after adding necessary additives such as a lubricant to the resulting granule, it is mixed and then molded with a rotary tableting machine. Can be manufactured. In addition, when the medicine has a bitter taste, the medicine or granules may be coated as necessary.
本発明のレーザー印刷用口腔内速崩壊錠は口腔内速崩壊錠にコーティング剤と金属酸化物とを分散させた液を噴霧し、薄膜層を形成することにより得られる。薄膜層形成後の口腔内崩壊時間は１５０秒以内であり、好ましくは１２０秒以内、より好ましくは９０秒以内である。これに関連し、レーザー印刷用のフィルムコーティング層の厚みは、コーティング剤の種類によって異なるが、一般に略１０μｍまでの厚みが好ましい。過剰な厚みを施すと崩壊時間が延長するからである。 The intraoral quick disintegrating tablet for laser printing of the present invention is obtained by spraying a liquid in which a coating agent and a metal oxide are dispersed in an intraoral quick disintegrating tablet to form a thin film layer. The oral disintegration time after the formation of the thin film layer is within 150 seconds, preferably within 120 seconds, and more preferably within 90 seconds. In this regard, the thickness of the film coating layer for laser printing varies depending on the type of coating agent, but generally a thickness of up to about 10 μm is preferable. This is because an excessive thickness increases the disintegration time.
本発明で用いられるコーティング剤として、例えば、ポリビニルアルコール（部分けん化物）、ポリビニルアルコール・ポリエチレングリコール共重合体又はポリビニルアルコール・ポリビニルアルコール・アクリル酸・メタクリル酸メチル共重合体等のポリビニルアルコール系重合体を挙げることができる。なかでも、ポリビニルアルコール（部分けん化物）やポリビニルアルコール・アクリル酸・メタクリル酸メチル共重合体が好ましい。
これらのコーティング剤の好ましい使用量は、その種類によって異なるが、一般に、素錠である口腔内速崩壊錠１００重量部に対し０．３〜１．０重量部であり、より好ましくは０．３５〜０．７重量部、さらに好ましくは０．４〜０．６重量部である。
As the coating agent used in the present invention, for example, polyvinyl alcohol (partially saponified product), polyvinyl alcohol / polyethylene glycol copolymer or polyvinyl alcohol polymer such as polyvinyl alcohol / polyvinyl alcohol / acrylic acid / methyl methacrylate copolymer. Can be mentioned. Of these, polyvinyl alcohol (partially saponified product) and polyvinyl alcohol / acrylic acid / methyl methacrylate copolymer are preferable.
Although the preferable usage-amount of these coating agents changes with kinds, generally it is 0.3-1.0 weight part with respect to 100 weight part of intraoral quick disintegrating tablets which are uncoated tablets, More preferably, it is 0.35. It is -0.7 weight part, More preferably, it is 0.4-0.6 weight part.
本発明で用いられる変色誘起金属酸化物としては、酸化マグネシウム、酸化亜鉛、酸化アルミニウム、アナターゼ型若しくはルチル型の酸化チタン、三二酸化鉄、黄色三二酸化鉄等が挙げられ、とりわけアナターゼ型若しくはルチル型の酸化チタン、三二酸化鉄又は黄色三二酸化鉄が好ましい。
これら変色誘起金属酸化物の好ましい使用量は、その種類によって異なるが、一般に、素錠である口腔内崩壊錠１００重量部に対し、０．０１〜０．２０重量部であり、より好ましくは０．０２〜０．１５重量部である。
Examples of the discoloration-inducing metal oxide used in the present invention include magnesium oxide, zinc oxide, aluminum oxide, anatase type or rutile type titanium oxide, iron sesquioxide, yellow iron sesquioxide, etc., and particularly anatase type or rutile type. Titanium oxide, ferric oxide or yellow ferric oxide are preferred.
Although the preferable usage-amount of these discoloration induction metal oxides changes with kinds, generally it is 0.01-0.20 weight part with respect to 100 weight part of orally disintegrating tablets which are uncoated tablets, More preferably, it is 0. 0.02 to 0.15 parts by weight.
フィルムコーティング方法は特に限定はされないが、一般的な通気型コーティング機や糖衣パン等を用いて行うことができる。 The film coating method is not particularly limited, but can be performed using a general air-permeable coating machine, sugar-coated bread, or the like.
レーザー印刷条件は特に限定はされないが、フィルムコーティング層表面に出力０．１〜１０Ｗ、波長２００〜５００ｎｍのＵＶレーザーを照射することにより印字することができる。 The laser printing conditions are not particularly limited, but printing can be performed by irradiating the surface of the film coating layer with a UV laser having an output of 0.1 to 10 W and a wavelength of 200 to 500 nm.
以下、参考例と実施例を挙げて本発明を説明する。
〔参考例〕口腔内速崩壊錠（素錠）の製造
部分アルファー化デンプン（ＰＣＳ／旭化成ケミカルズ製）７９２．５ｇを流動層造粒乾燥コーティング機（ＭＰ−０１ＳＰＣ型／パウレック製）に投入し、これに、予めドネペジル塩酸塩２５０ｇ（ＴＥＶＡ製）及びポリビニルアルコール・アクリル酸・メタクリル酸メチル共重合体（ＰＯＶＡＣＯＡＴ／大同化成工業製）７．５ｇを精製水７５０ｇに溶解・分散させた液を噴霧し、レイヤリング造粒した。次いで、ポリビニルアルコール共重合体２０ｇ及びタルク（クラウンタルク／松村産業製）を精製水１，３００ｇに溶解・分散させた液を噴霧してコーティングし、乾燥した。この乾燥造粒物に、さらにメタクリル酸コポリマーＬＤ（オイドラギッドＬ３０Ｄ５５／エボニック・テグサ・ジャパン製）１，５００ｇ、Ｄ−マンニトール（マンニットＰ／三菱フードテック製）１２５ｇ、タルク１２５ｇ及びクエン酸トリエチル（シトロフレックス２ＳＣ−６０／森村商事製）を精製水１，８７５ｇに溶解・分散した液でコーティングし、乾燥して、コーティング顆粒を得た。
このコーティング顆粒とＤ−マンニトール３８９０．５ｇ、結晶セルロース（セオラスＫＧ−８０２／旭化成ケミカルズ製）及び低置換度ヒドロキシプロピルセルロース（ＮＢＤ−０２２／信越化学製）１，０００ｇを流動層造粒乾燥コーティング機（ＦＤ−ＧＰＣＧ−５ＳＰＣ型／パウレック製）に投入し、ヒドロキシプロピルセルロース（ＨＰＣ−Ｌ／日本曹達製）９０ｇを精製水２，９１０ｇに溶解した液を噴霧しながら造粒し、乾燥して造粒顆粒を得た。
この造粒顆粒を結晶セルロース１５０ｇ、ｌ−メントール（小林桂製）１２ｇ、アスパルテーム（味の素製）１５０ｇ、香料（ドライコートストロベリー／高田香料製）７．５ｇ及びステアリン酸マグネシウム（太平化学産業製）１００ｇと共に混合し、ロータリー式打錠機（クリーンプレスコレクト１９Ｋ型／菊水製作所製）にて打錠して、1錠質量１９０ｍｇ、直径８ｍｍ、口腔内崩壊時間約３０秒のドネペジル塩酸塩口腔内崩壊錠（素錠）を得た。
The present invention will be described below with reference examples and examples.
[Reference Example] Manufacture of intraorally rapidly disintegrating tablets (plain tablets) 792.5 g of partially pregelatinized starch (PCS / Asahi Kasei Chemicals) was charged into a fluidized bed granulation drying coating machine (MP-01SPC / Pauleck), To this was sprayed a solution in which 250 g of donepezil hydrochloride (manufactured by TEVA) and 7.5 g of polyvinyl alcohol / acrylic acid / methyl methacrylate copolymer (POVACOAT / manufactured by Daido Kasei Kogyo) were dissolved and dispersed in 750 g of purified water. , Granulated layering. Next, 20 g of polyvinyl alcohol copolymer and talc (Crown Talc / manufactured by Matsumura Sangyo) were dissolved and dispersed in 1,300 g of purified water, sprayed, coated, and dried. To this dried granulated product, methacrylic acid copolymer LD (Eudragid L30D55 / Evonik Tegusa Japan) 1,500 g, D-mannitol (Mannit P / Mitsubishi Foodtech) 125 g, talc 125 g and triethyl citrate (Citro) Flex 2SC-60 / manufactured by Morimura Corporation) was coated with a solution dissolved and dispersed in 1,875 g of purified water and dried to obtain coated granules.
Fluidized bed granulation drying coating machine using this coated granule, 3890.5 g of D-mannitol, 1,000 g of crystalline cellulose (Theolas KG-802 / Asahi Kasei Chemicals) and low substituted hydroxypropyl cellulose (NBD-022 / Shin-Etsu Chemical) (FD-GPCG-5SPC / manufactured by POWREC), granulated while spraying a solution of 90 g of hydroxypropylcellulose (HPC-L / manufactured by Nippon Soda) in 2,910 g of purified water, dried and formed Granules were obtained.
This granulated granule is 150 g of crystalline cellulose, 12 g of 1-menthol (manufactured by Katsura Kobayashi), 150 g of aspartame (manufactured by Ajinomoto Co., Inc.), 7.5 g of fragrance (manufactured by dry coat strawberry / Takada fragrance) and 100 g of magnesium stearate (manufactured by Taihei Chemical Sangyo). And tableted with a rotary tableting machine (clean press collect 19K / manufactured by Kikusui Seisakusho). One tablet mass 190mg, diameter 8mm, oral disintegration tablet about 30 seconds (Uncoated tablet) was obtained.
（１）レーザー印刷用口腔内崩壊錠の製造
参考例で得られた口腔内崩壊錠１９０ｇをコーティング機（ＤＲＣ−２００型／パウレック製）に投入し、これに、予めポリビニルアルコール・アクリル酸・メタクリル酸メチル共重合体（ＰＯＶＡＣＯＡＴ／大同化成工業製）１．９ｇ及び酸化チタン（アナターゼ型／フロイント産業製）０．１ｇを精製水３８ｇに加え、超音波分散装置を用い、酸化チタンの平均粒子径が１μｍ以下に均一分散させた液を噴霧し、1錠質量１９１ｍｇになるまでコーティングし、乾燥して口腔内崩壊時間が約６０秒のレーザー印刷用口腔内崩壊錠を得た。
（２）ＵＶレーザー印刷
前記（１）で得られたレーザー印刷用口腔内崩壊錠をＵＶレーザーマーキング装置（ＬＩＳ−２５０型／クオリカプス製）にてＰＥ＝４４％、４０，０００Ｈｚの条件でレーザー印刷を施し、レーザー印刷口腔内崩壊錠を得た。
(1) Manufacture of orally disintegrating tablet for laser printing 190 g of orally disintegrating tablet obtained in Reference Example was put into a coating machine (DRC-200 type / manufactured by POWREC), and polyvinyl alcohol / acrylic acid / methacrylic was previously added thereto. 1.9 g of acid methyl copolymer (POVACOAT / manufactured by Daido Kasei Kogyo) and 0.1 g of titanium oxide (manufactured by Anatase / Freund Sangyo) are added to 38 g of purified water, and an average particle diameter of titanium oxide using an ultrasonic dispersing device. Was sprayed with a solution uniformly dispersed to 1 μm or less, coated to a tablet weight of 191 mg, and dried to obtain an orally disintegrating tablet for laser printing having an oral disintegration time of about 60 seconds.
(2) UV laser printing The orally disintegrating tablet for laser printing obtained in the above (1) is laser-printed under the conditions of PE = 44% and 40,000 Hz with a UV laser marking device (LIS-250 type / Qualicaps). The laser-printed orally disintegrating tablet was obtained.
参考例で得られた口腔内崩壊錠１９０ｇをコーティング機（ＤＲＣ−２００型／パウレック製）に投入し、これにポリビニルアルコール・アクリル酸・メタクリル酸メチル共重合体（ＰＯＶＡＣＯＡＴ／大同化成工業製）１．６ｇ及び酸化チタン（アナターゼ型／フロイント産業製）０．４ｇを精製水３８ｇに加え、超音波分散装置を用い、酸化チタンの平均粒子径が１μｍ以下に均一分散ささせた液を噴霧し、1錠質量１９１ｍｇになるまでコーティングし、乾燥して口腔内崩壊時間が約６０秒のレーザー印刷用口腔内崩壊錠を得た。これに実施例１と同条件でレーザー印刷を施し、レーザー印刷口腔内崩壊錠を得た。 190 g of the orally disintegrating tablet obtained in the reference example was put into a coating machine (DRC-200 type / manufactured by POWREC), and polyvinyl alcohol / acrylic acid / methyl methacrylate copolymer (POVACOAT / manufactured by Daido Kasei Kogyo) 1 .6 g and titanium oxide (anatase type / Freund Sangyo) 0.4 g are added to 38 g of purified water, and an ultrasonic dispersion apparatus is used to spray a liquid in which the average particle diameter of titanium oxide is uniformly dispersed to 1 μm or less. One tablet was coated to a mass of 191 mg and dried to obtain an orally disintegrating tablet for laser printing having an oral disintegration time of about 60 seconds. This was laser-printed under the same conditions as in Example 1 to obtain a laser-printed orally disintegrating tablet.
〔比較例１〕
参考例で得られた口腔内崩壊錠１９０ｇをコーティング機（ＤＲＣ−２００型／パウレック製）に投入し、これに、予めポリビニルアルコール・アクリル酸・メタクリル酸メチル共重合体（ＰＯＶＡＣＯＡＴ／大同化成工業製）１ｇ及び酸化チタン（アナターゼ型／フロイント産業製）１ｇを精製水３８ｇに加え、超音波分散装置を用い、酸化チタンの平均粒子径が１μｍ以下に均一分散させた液を噴霧し、1錠質量１９１ｍｇになるまでコーティングし、乾燥して口腔内崩壊時間約６０秒のレーザー印刷用口腔内崩壊錠を得た。これに実施例１と同条件でレーザー印刷を施し、レーザー印刷口腔内崩壊錠を得た。
[Comparative Example 1]
190 g of the orally disintegrating tablet obtained in the reference example was put into a coating machine (DRC-200 type / manufactured by POWREC), and polyvinyl alcohol / acrylic acid / methyl methacrylate copolymer (POVACOAT / manufactured by Daido Kasei Kogyo Co., Ltd.) in advance. ) 1 g and 1 g of titanium oxide (anatase type / Freund Sangyo) 1 g are added to 38 g of purified water, and an ultrasonic dispersion device is used to spray a liquid in which the average particle diameter of titanium oxide is uniformly dispersed to 1 μm or less, and 1 tablet mass It was coated to 191 mg and dried to obtain an orally disintegrating tablet for laser printing having an oral disintegration time of about 60 seconds. This was laser-printed under the same conditions as in Example 1 to obtain a laser-printed orally disintegrating tablet.
〔比較例２〕
参考例で得られた口腔内崩壊錠１９０ｇをコーティング機（ＤＲＣ−２００型／パウレック製）に投入し、これに、予め酸化チタン（アナターゼ型／フロイント産業製）１ｇを精製水３９ｇに加え、超音波分散装置を用い、酸化チタンの平均粒子径が１μｍ以下に均一分散させた液を噴霧し、1錠質量１９１ｍｇになるまでコーティングし、乾燥して口腔内崩壊時間約３０秒のレーザー印刷用口腔内崩壊錠を得た。これに実施例１と同条件でレーザー印刷を施し、レーザー印刷口腔内崩壊錠を得た。
[Comparative Example 2]
190 g of the orally disintegrating tablet obtained in the reference example was put into a coating machine (DRC-200 type / manufactured by POWREC), and 1 g of titanium oxide (anatase type / manufactured by Freund Sangyo) was added to 39 g of purified water in advance. Using a sonic dispersing device, spray a liquid in which the average particle diameter of titanium oxide is uniformly dispersed to 1 μm or less, coat it until the weight of one tablet reaches 191 mg, dry it, and oral cavity for laser printing with an oral disintegration time of about 30 seconds An internally disintegrating tablet was obtained. This was laser-printed under the same conditions as in Example 1 to obtain a laser-printed orally disintegrating tablet.
〔比較例３〕
参考例で得られた口腔内崩壊錠１９０ｇをコーティング機（ＤＲＣ−２００型／パウレック製）に投入し、これに、予めヒプロメロース（ＴＣ−５（Ｅ）／信越化学製）１．９ｇ及び酸化チタン（アナターゼ型／フロイント産業製）０．１ｇを精製水３８ｇに加え、超音波分散装置を用い、酸化チタンの平均粒子径が１μｍ以下に均一分散させた液を噴霧し、1錠質量１９１ｍｇになるまでコーティングし、乾燥して口腔内崩壊時間約６０秒のレーザー印刷用口腔内崩壊錠を得た。これに実施例１と同条件でレーザー印刷を施し、レーザー印刷口腔内崩壊錠を得た。
[Comparative Example 3]
190 g of the orally disintegrating tablet obtained in the reference example was put into a coating machine (DRC-200 type / manufactured by POWREC), and 1.9 g of hypromellose (TC-5 (E) / manufactured by Shin-Etsu Chemical) and titanium oxide were previously added thereto. (Anatase / Freund Sangyo) 0.1 g is added to 38 g of purified water, and an ultrasonic dispersion device is used to spray a liquid in which the average particle size of titanium oxide is uniformly dispersed to 1 μm or less, resulting in a tablet weight of 191 mg. And dried to obtain an orally disintegrating tablet for laser printing having an oral disintegration time of about 60 seconds. This was laser-printed under the same conditions as in Example 1 to obtain a laser-printed orally disintegrating tablet.
〔比較例４〕
参考例で得られた口腔内崩壊錠１９０ｇをコーティング機（ＤＲＣ−２００型／パウレック製）に投入し、これに、予めヒドロキシプロピルセルロース（ＨＰＣ−ＳＳＬ／日本曹達製）１．９ｇ及び酸化チタン（アナターゼ型／フロイント産業製）０．１ｇを精製水３８ｇに加え、超音波分散装置を用い、酸化チタンの平均粒子径が１μｍ以下に均一分散させた液を噴霧し、1錠質量１９１ｍｇになるまでコーティングし、乾燥して口腔内崩壊時間約６０秒のレーザー印刷用口腔内崩壊錠を得た。これに実施例１と同条件でレーザー印刷を施し、レーザー印刷口腔内崩壊錠を得た。
[Comparative Example 4]
190 g of the orally disintegrating tablet obtained in the reference example was put into a coating machine (DRC-200 type / manufactured by POWREC), and 1.9 g of hydroxypropyl cellulose (HPC-SSL / manufactured by Nippon Soda) and titanium oxide ( Anatase / Freund Sangyo Co., Ltd.) 0.1 g is added to 38 g of purified water, and an ultrasonic dispersion device is used to spray a liquid in which the average particle size of titanium oxide is uniformly dispersed to 1 μm or less until one tablet mass reaches 191 mg. It was coated and dried to obtain an orally disintegrating tablet for laser printing having an orally disintegrating time of about 60 seconds. This was laser-printed under the same conditions as in Example 1 to obtain a laser-printed orally disintegrating tablet.
以上の実施例と参考例において使用したコーティング剤と酸化チタンの1錠当りの配合比率（参考例の素錠１００重量部に対する重量部）を表１に示した。
Table 1 shows the blending ratio of the coating agent and titanium oxide used in the above Examples and Reference Examples per tablet (parts by weight relative to 100 parts by weight of the base tablet of Reference Example).
〔レーザー印刷文字の識別性の比較〕
図１に示すとおり、実施例１及び実施例２の印刷は、比較例１〜４の印刷とくらべ顕著に鮮明であり、識別が容易である。
[Comparison of laser print character discrimination]
As shown in FIG. 1, the printing in Example 1 and Example 2 is significantly clearer than the printing in Comparative Examples 1 to 4, and is easy to identify.
本発明によれば、医療現場に医薬の識別性が高い口腔内崩壊錠を提供することができ、投薬過誤の防止に有効である。 ADVANTAGE OF THE INVENTION According to this invention, the orally disintegrating tablet with high discrimination | determination of a pharmaceutical can be provided in a medical field, and it is effective in prevention of a medication error.
図中の実施例１、実施例２、参考例１、参考例２、参考例３及び参考例４は、それぞれ各例で得られた錠剤を意味する。
In the figure, Example 1, Example 2, Reference Example 1, Reference Example 2, Reference Example 3 and Reference Example 4 refer to the tablets obtained in each example.
Claims (4)
The method according to claim 1, wherein the polyvinyl alcohol-based polymer is a polyvinyl alcohol / acrylic acid / methyl methacrylate copolymer, and the discoloration-inducing metal oxide is anatase-type titanium oxide.
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| JP2015120678A (en) * | 2013-12-24 | 2015-07-02 | キョーリンリメディオ株式会社 | Two-layer coated tablet for uv laser printing, and production method thereof |
| JP5830618B1 (en) * | 2015-01-30 | 2015-12-09 | 大原薬品工業株式会社 | Method for producing multilayer film coated tablets for laser printing |
| CN107848297A (en) * | 2015-09-02 | 2018-03-27 | 株式会社斯库林集团 | Tablet printing equipment and tablet printing process |
| JP2018065752A (en) * | 2016-10-17 | 2018-04-26 | 東和薬品株式会社 | Silodosin-containing pharmaceutical composition and method for producing the same |
| US10588856B2 (en) | 2014-02-12 | 2020-03-17 | Sawai Pharmaceutical Co., Ltd. | Orally disintegrating tablet coated with film |
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